The European Crohn’s and Colitis Organisation (“ECCO”) released a statement last week supporting the switch from the reference infliximab to biosimilar infliximab in patients with inflammatory bowel disease (“IBD”). ECCO’s new position is particularly significant, given its earlier position taking a cautious approach to biosimilars and suggesting that “rigorous testing [of biosimilars]…
President Barack Obama will be joined today by Vice President Biden, House Energy and Commerce Committee Chairman Fred Upton (R-MI), and other Congressional leaders for the signing ceremony for the 21st Century Cures Act. The signing ceremony will take place at 2:30 pm ET. The bill signing will be live streamed here beginning…
Today, the Supreme Court denied certiorari in Apotex v. Amgen, a closely-watched case involving the interpretation of key provisions of the BPCIA. Our most recent blog coverage can be found here. Even though the Court has declined to hear Apotex v. Amgen, the Supreme Court has before it another vehicle for addressing the hotly-contested…
As we posted earlier this week, the Acting Solicitor General (“SG”), on December 7th, filed an amicus brief in which it (a) recommended that the Supreme Court grant Sandoz’s cert petition and Amgen’s conditional cross-cert petition regarding how to interpret important provisions of the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), and…
Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for Biosimilar Drugs (“Guidance”). The Biologics and Genetic Therapies Directorate (BGTD) within the Health Products and Food Branch of Health Canada is the…
This past April, the FDA approved Inflectra® (infliximab-dyyb), Celltrion and Hospira’s biosimilar of Janssen’s Remicade®. According to papers filed in the Federal Circuit this week, Celltrion and Hospira (collectively, “Celltrion”) have now launched Inflectra® in the United States. On December 6, Celltrion stated that it “recently launched in the United…
The Acting Solicitor General has just filed an amicus brief recommending that Sandoz’s cert petition and Amgen’s cross-petition be granted. The Acting Solicitor General also argues that the decision by the Federal Circuit on the 180-day delay was incorrect. Amgen’s supplemental brief in response will be due December 21. The Court will…
In a 94-5 vote, the U.S. Senate today passed the 21st Century Cures Act (H.R.34). This vote comes just days after the House of Representatives voted in favor of the bill. The bill now heads to President Obama, who has been a vocal proponent of the bill and has stated…
The past few days have seen a lot of activity on the rituximab biosimilar front. According to a joint press release, Sanofi and JHL Biotech, a biopharmaceutical company based in China, formed an alliance to collaborate on the development and commercialization of a rituximab biosimilar and various pharmaceutical products in China….
Earlier this year, we reported that Mylan and Biocon submitted an aBLA for MYL-1401O, a proposed biosimilar to Genentech’s Herceptin® (trastuzumab). Earlier this week, an article published in the Journal of the American Medical Association (JAMA), titled Effect of a Proposed Trastuzumab Biosimilar Compared With Trastuzumab on Overall Response Rate in Patients With ERBB2…